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This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.

Condition or disease

Intervention/treatment

Phase

Erectile Dysfunction

Device: "MEDISPEC" treatment probe

Phase 3

Detailed Description:

This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment

International Index of Erectile function- Erectile Function Domain [ Time Frame: At screening and 17 weeks later at last visit ]

An increase in score of 5points and above will be considered success.

Secondary Outcome Measures
:

Rigidity scale [ Time Frame: At screening and 17 weeks later at last visit ]

A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success

Flow Mediated Dilatation Technique [ Time Frame: At screening and 17 weeks later at last visit ]

A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success.

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